There are rare reports of hepatocellular carcinoma in patients receiving long-term oral therapy with androgens in high doses.
Withdrawal of the drugs did not lead to regression of the tumors in all cases.Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of testosterone replacement therapy.In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men.
Testim® is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range.Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.These men have low testosterone serum levels but have gonadotropins in the normal or low range.Testim® has not been clinically evaluated in males under 18 years of age.
Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.
Testim® is not indicated for use in women, has not been evaluated for use in women, and must not be used in women.Pregnant and nursing women should avoid skin contact with Testim® application sites on men.
Testosterone may cause fetal harm.
Testosterone exposure during pregnancy has been reported to be associated with fetal abnormalities.
In the event that unwashed or unclothed skin to which Testim® has been applied comes in direct contact with the skin of a pregnant or nursing woman, the general area of contact on the woman should be immediately washed with soap and water.Testim® should not be used in patients with known hypersensitivity to any of its ingredients, including testosterone USP that is chemically synthesized from soy.
Testim® should not be applied to the abdomen.Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatitis, hepatic neoplasms, cholestatic hepatitis, and jaundice).
Peliosis hepatitis can be a life-threatening or fatal complication.
Long-term therapy with testosterone enanthate, which elevates blood levels for prolonged periods has produced multiple hepatic adenomas.
Transdermal testosterone is not known to produce these adverse effects.Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of testosterone replacement therapy.
In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men (see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility and Laboratory Tests).Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease.
In addition to discontinuation of the drug, diuretic therapy may be required.
Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism.The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.